GIM · Tubes, Vacuum Sample, With Anticoagulant
Clinical Chemistry · 21 CFR 862.1675 · Class 2
Overview
| Product Code | GIM |
|---|---|
| Device Name | Tubes, Vacuum Sample, With Anticoagulant |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 39)
Showing 20 most recent of 39 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240455 | BD Vacutainer® Citrate Blood Collection Tubes | Becton, Dickinson and Company | Oct 31, 2024 | SESE |
| K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | Becton, Dickinson and Company | Nov 27, 2023 | SESE |
| K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes | Becton, Dickinson and Company | Aug 25, 2023 | SESE |
| K162723 | TransFix/EDTA Vacuum Blood Collection Tubes | Caltag Medsystems, Ltd. | Jun 22, 2017 | SESE |
| K080552 | CYTO-CHEX BCT | Streck | Jul 31, 2008 | SESE |
| K012152 | DS30 HCY BLOOD COLLECTION TUBES | Drew Scientific , Ltd. | Sep 18, 2001 | SESE |
| K971449 | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) | Becton Dickinson Vacutainer Systems | Jun 17, 1997 | SESE |
| K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner America, Inc. | May 2, 1997 | SESE |
| K951886 | LOK-ON NEEDLE DISPOSAL SYSTEM | Becton Dickinson Vacutainer Systems | Jun 30, 1995 | SESE |
| K945458 | VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 6, 1995 | SESE |
| K944814 | CORVAC PLASTIC BLOOD COLLECTION TUBE | Sherwood Medical Co. | Dec 19, 1994 | SESE |
| K940058 | MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER | Sherwood Medical Co. | May 2, 1994 | SESE |
| K933939 | BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT | Organon Teknika Corp. | Feb 7, 1994 | SESE |
| K933386 | VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 12, 1993 | SESE |
| K922858 | MULTIDRAW SYSTEM | Cambridge Multi-Draw, Inc. | Nov 16, 1992 | SESK |
| K922468 | ANGEL WING SETS -- MODIFIED | Mbo Laboratories, Inc. | Jul 10, 1992 | SESE |
| K921778 | DIRECTDRAW SUPERSERUM | International Technidyne Corp. | May 28, 1992 | SESE |
| K921636 | VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 29, 1992 | SESE |
| K920184 | ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD. | Mbo Laboratories, Inc. | Feb 18, 1992 | SESE |
| K915213 | CORVAC BLOOD COLLECTION TUBE | Sherwood Medical Co. | Jan 8, 1992 | SESE |
Top Applicants
- Sherwood Medical Industries — 5 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- Becton, Dickinson and Company — 3 clearances
- Jelco Laboratories — 3 clearances
- Sherwood Medical Co. — 3 clearances
